AuthorisedTherapeutic exploratory (Phase II)Interventional

Receptor radionuclide therapy with 177Lu-DOTATOC (177Lu- edotreotide or 177Lu-octreotide) in SSTR positive patients: a multicenter, prospective, phase II trial

This medical study is looking into a treatment called 177Lu-DOTATOC for people who have certain types of cancer like neuroendocrine tumours (NETs), pheochromocytomas, paragangliomas, and other similar cancers. This treatment uses a small amount of radiation to target cancer cells. The main goal is to see how many patients experience their tumours shrinking or staying stable after receiving this treatment. Researchers will also be checking for any side effects and how the treatment affects patients' general well-being and quality of life. This is a Phase II trial, meaning it's a further step to understand if the treatment is safe and effective in a larger group of people, after earlier smaller studies have shown promise. It's for adults aged 18 and over.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Enrolment target

178

Start

13 Jan 2025

NET Neuroendocrine Tumor Other SSTR-positive tumours NETs retreated with PRRT Pheochromocytomas and paragangliomas Bronchopulmonary and other NETs

What is this study about?

This study is investigating a new type of treatment for certain cancers, including neuroendocrine tumours (NETs), which are uncommon cancers that develop in hormone-producing cells. This treatment is called 177Lu-DOTATOC, and it works by delivering radiation directly to the cancer cells. The 'Lu' stands for Lutetium, which is a radioactive substance, and 'DOTATOC' is a special molecule that helps carry the radiation specifically to the cancer cells, leaving healthy cells mostly untouched. This approach is sometimes referred to as 'targeted radiation therapy'.

The main purpose of this study is to observe how effective this new treatment is. Researchers want to find out what percentage of patients experience their tumours shrinking or stopping their growth after receiving the treatment. They will also be carefully monitoring any side effects to understand how safe the treatment is. Additionally, they will be looking at how long people live after starting the treatment and how their general health and quality of life are affected.

This is a Phase II study, which means while it's still an experimental treatment, it has already shown some promise in earlier, smaller studies. This phase allows researchers to gather more information on effectiveness and safety in a larger group of patients before considering it for wider use. It's an important step in helping to develop new and potentially better ways to treat these specific types of cancer.

Key takeaways

Tests a new radiation treatment (177Lu-DOTATOC) for specific cancers.
Aims to see if it shrinks or stabilises tumours in NETs and similar conditions.
Will closely monitor for any side effects and impact on patient well-being.
It's a Phase II study, meaning it's an important step in researching a new treatment.
Open to adults aged 18 and over with certain types of neuroendocrine cancers.
Participation involves regular check-ups, tests, and follow-up after treatment.

Who may be eligible?

This study is open to adults aged 18 years and older, regardless of whether they are male or female. You might be suitable for this study if you have been diagnosed with certain types of cancer. These include neuroendocrine tumours (NETs), which are cancers that start in hormone-producing cells throughout the body.

The study also includes other specific types of cancer that are similar to NETs, such as pheochromocytomas and paragangliomas, which are rare tumours that often develop in or near the adrenal glands. If you have a NET in your lungs or other areas, or if you have previously had a similar treatment (PRRT) for your NETs and are being considered for more treatment, you might also be eligible. The key is that your cancer must have a specific characteristic, meaning it has 'SSTR' markers, which the study treatment targets.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Have you been diagnosed with a neuroendocrine tumour (NET)?
Do you have a different SSTR-positive tumour, such as pheochromocytoma or paraganglioma?
Has your doctor confirmed your tumour has 'SSTR' markers?
Are you considering further treatment for RETs if you've had PRRT before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the 177Lu-DOTATOC treatment. The study team will need to monitor your health closely throughout this period. This will involve regular visits to the clinic for medical check-ups, blood tests, and scans to see how your body is responding to the treatment and how the tumour is behaving.

Before treatment begins, you will have a baseline assessment, which includes various tests to get a picture of your health. During the treatment period, typically at the start of each treatment cycle, you will be asked to fill out questionnaires about your quality of life. After your last treatment, you will have follow-up appointments for a period, where doctors will continue to check your health and the status of your cancer. The total duration of your involvement will depend on how you respond to the treatment and the follow-up schedule determined by the study, but monitoring could last for several months after your last treatment.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't widely available yet, which might help to shrink your tumour or slow its growth. However, like all medical treatments, 177Lu-DOTATOC may have side effects, which could range from mild to severe. The study team will carefully monitor you for any side effects and will explain these to you fully before you decide to take part. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is 177Lu-DOTATOC?

It's a new targeted radiation treatment for certain cancers, using a special molecule to deliver radiation directly to cancer cells.

What types of cancer is this study for?

It's mainly for neuroendocrine tumours (NETs) and similar cancers like pheochromocytomas and paragangliomas, especially those with 'SSTR' markers.

What does a 'Phase II' study mean?

It means the treatment has shown promise in earlier studies, and now researchers are testing it in more people to understand its effectiveness and safety better.

What will my doctor be looking for in this study?

Doctors will mainly be looking to see if your tumour shrinks or stops growing, and they will also monitor for any side effects and how you feel generally.

Do I have to do anything special if I join?

You'll have regular clinic visits, blood tests, scans, and possibly fill out questionnaires about your well-being.